FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half ... “We need to build factories … because our research and ...

MILAN, Italy, May 6, 2025 - Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted ...

Because price and margin headwinds exist predominantly in small-molecule oral tablets that are easy to produce, we expect Viatris’ future pipeline to focus more on complex generics—drugs that have ...

Vir Biotechnology, Inc. progresses HDV treatment with promising ECLIPSE program results. Click for my updated look at VIR ...

CROSSJECT and its EUROFINS CDMO partner successfully completed the aseptic filling of all ZEPIZURE® registration batches and anticipate the delivery of the last manufacturing data needed for U.S. Food ...